Development of a Model for Inspection and Evaluation of Medical Devices

Abstract

The objective of this research is to identify the methods to improve current inspection and evaluation strategies for medical devices in health facilities. The research aims to emphasize the effect of proposed model variables (documents, visual inspection, risk management, preventive maintenance, performance indicators, corrective maintenance, inventory management, policies and procedures and vocational performance) on the dependent variable (the development of health care). The most important objectives include, establish a metrology model to reduce medical risk and optimizing health care quality. Evaluate the work of medical devices based on the recommendations of the World Health Organization and create a system, which provide cost-oriented re-diagnosis rate of non-accuracy of the results. This work focuses on the current situation of medical devices in Military Hospital and Khartoum Hospital has been assessed according to designed model. The model was designed, consistent with The Joint Commission for Accreditation of Healthcare Organizations (JCAHO), Operating Guide for TOE Medical Equipment Maintenance (Headquarters Department of the Army, Washington, DC, 2006), WHO Medical device technical series (2011), Jordanian Royal Medical Services ("Auditor Guide for quality", 2007) , ISO 14971(2007) and successful practices of other countries’ systems. A model was applied by interviewing the heads and biomedical engineers of the sample facilities at some departments and sections that working with medical devices in the Military Hospital (17) unit and Khartoum Hospital (8) unit, visual inspection and performance indicator for medical devices. The survey data related to the model are analyzed by the IBM SPSS statistics soft wear program version 20.0 - 2011 by using the statistical methods such as the mean, frequencies, percentages and independent T – test. Results obtained by model reflected the state of medical devices in hospitals. However, the average percentage of standards inspection and evaluation of medical devices which reached at Military Hospital is (46.8%) and Khartoum Hospital is (47.9 %). The research results indicated that there were No significance differences between the assessments of medical equipment of Military Hospital and Khartoum Hospital because the P. value of independent T – test =.744 and it was greater than (0.05) . The results indicated evidence to support the null hypothesis that current inspection and evaluation activities for medical devices may have negative effect in the development of healthcare facilities.